Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids

NCT02487381 | Completed Phase 1

• 1 other identifier: GEI-TCP II
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. In addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal processing assessed by EEG and fMRI.

Conditions

Healthy; Modeling Psychosis

Keywords

delta-9-tetrahydrocannabinol; cannabidiol; COMT; Volunteers

Outcome Measures

Primary Outcomes (1)

• Change in Positive and Negative Syndrome Scale total score (PANSS T) from baseline to post drug intake of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural synchrony.

  up to 4 hours

Secondary Outcomes (7)

• Change in Positive and Negative Syndrome Scale (PANSS) subscores and clusters (baseline to post drug intake)

  up to 4 hours

• Change in neuropsychological parameters

  up to 6 hours

• Assessment of hallucinogen states (APZ) (post drug intake)

  1 day

• Safety and tolerability assessments including (S)AEs, physical examination, vital signs (including heart rate and systolic and diastolic blood pressure in both supine and standing positions), and detailed laboratory assessments

  1 day

• Metabolic markers post drug intake (blood)

  up to 4 hours

Other Outcomes (1)

• Assessment of biomarker profiles in serum and cerebrospinal fluid of subjects.

  1 day

Study Arms (4)

THC

EXPERIMENTAL

Subjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules.

Drug: delta-9-tetrahydrocannabinol; Drug: Placebo

CBD

EXPERIMENTAL

Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules.

Drug: Cannabidiol; Drug: Placebo

CBD+THC

EXPERIMENTAL

Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) a

Drug: delta-9-tetrahydrocannabinol; Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Subjects receive corresponding delta-9-tetrahydrocannabinol and cannabidiol placebo capsules

Drug: Placebo

Interventions

delta-9-tetrahydrocannabinol DRUG

Also known as: Dronabinol

CBD+THC; THC

Cannabidiol DRUG

CBD; CBD+THC

Placebo DRUG

CBD; Placebo; THC

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent given by the subject
• Healthy young man (age between 18 and 45) insightful to the study (WST\> 95)
• Right handedness
• At least one time consumption of Cannabis but less than 10 times/ per lifetime, no consumption of other psychotropic agents (despite coffee or nicotine), no alcohol abuse
• Negative drug-screening at the time of screening
• Body Mass Index between 18 and 30

You may not qualify if:

• Lack of accountability
• Participation in other interventional trials
• Severe medical or neurological illness, especially cardiovascular, renal, advanced respiratory, hematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
• Any known psychiatric illness in the participant's history
• Known family history concerning psychiatric disorders
• Cannabis consumption within the last six months
• Consumption of any illegal drugs (except cannabis in history, see above)
• Intake of interfering medication, at the discretion of the investigator
• High intracranial pressure
• Any disorders in stereoscopic vision (measured by the TNO-Test, Lamerics, Utrecht) or hearing deficits
• Contraindications due to the Investigators Brochure Contraindication for Magnetic Resonance Imaging (e.g. cardiac pacemaker, claustrophobia, attached brace, in body metal, tattoos) or lumbar puncture (e.g. local or systemic infection, disturbance of blood coagulation, medication with anticoagulants like Phenprocoumon)

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Related Publications (1)

• Woelfl T, Rohleder C, Mueller JK, Lange B, Reuter A, Schmidt AM, Koethe D, Hellmich M, Leweke FM. Effects of Cannabidiol and Delta-9-Tetrahydrocannabinol on Emotion, Cognition, and Attention: A Double-Blind, Placebo-Controlled, Randomized Experimental Trial in Healthy Volunteers. Front Psychiatry. 2020 Nov 13;11:576877. doi: 10.3389/fpsyt.2020.576877. eCollection 2020.

  PMID: 33304282 DERIVED

MeSH Terms

Interventions

Dronabinol; Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. F. Markus Leweke

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 1, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 17, 2015

Record last verified: 2015-08

Locations

DE (1)